Use of Probiotics to Prevent Cholangitis in Children With Biliary Atresia After the Kasai Portoenterostomy

NCT00166868 | Completed

• 1 other identifier: 921201
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Abstract Biliary atresia (BA) is an idiopathic, progressive, and fatal disease if untreated. Since Kasai first introduced the operation for BA in 1959, there have been encouraging results in treating this disease. Ascending cholangitis is a frequent and often recurrent complication. It may worsen the prognosis, with an increase in mortality, secondary failure of restoration of bile flow, and possible exacerbation of portal hypertension. For patients who have had restoration of bile flow with a timely portoenterostomy, the recurrence of ascending cholangitis is the single most significant variable pertaining to long-term prognosis. Patients with multiple episodes of ascending cholangitis are more likely to require liver transplantation than those without multiple recurrences. Therefore, the prevention of cholangitis is crucial in the management of patients who have had a Kasai portoenterostomy. Some oral antibiotics, like trimethoprim-sulfamethoxazole (TMP/SMZ) and neomycin have showed the effect to prevent against ascending cholangitis. But, we should consider the problem of drug resistance after long-term use of antibiotics. Is there any better and safer treatment? Probiotics are live microorganisms, which have beneficial effects on human health. Many studies have showed that probiotics have effects to treat or prevent intestinal infection or inflammation even for patient after liver transplantation. The aim of this study is to investigate the possibility of use of probiotics in prophylaxis of ascending cholangitis. We want to enroll 20 BA patients aged 0 to 3 years, who had a Kasai operation. Ten patients are treated with neomycin (25 mg/kg/d, qid, 4 days a week). Another 10 patients receive Lactobacillus casei rhamnosus, Lcr 35 (8x108 CFU/day, bid) The duration of treatment is 6 months. Bacterial cultures of stool are performed before treatment and 1 month, 3 months and 6 months after treatment to evaluate the change of intestinal flora. Another 10 BA patients, from 1991 to 1996, aged 0 to 3 years, without prophylaxis after portoenterostomy, were served as the historical control group. Comparisons of the episodes of cholangitis, time to the first episode, and body weight change are made among the three groups.

Conditions

Biliary Atresia

Keywords

Biliary atresia, cholangitis, probiotics, prophylaxis

Outcome Measures

Primary Outcomes (1)

• episodes of cholangitis

  episodes of cholangitis during 6 months of intervention

  6 months after intervention

Secondary Outcomes (1)

• gain of body weight

  6 months after intervention

Study Arms (3)

Neomycin prescribed

EXPERIMENTAL

Interventions: 10 cases received Neomycin for 6 months

Drug: Neomycin

Probiotics (Lactobacillus casei rhamnosus, Lcr35) prescribed

EXPERIMENTAL

Interventions: 10 cases received Probiotics for 6 months

Drug: Lactobacillus casei rhamnosus (Lcr35)

control

NO INTERVENTION

10 cases without intervention were historical control.

Interventions

Lactobacillus casei rhamnosus (Lcr35) DRUG

Probiotics (Lactobacillus casei rhamnosus, Lcr35) prescribed

Neomycin DRUG

Neomycin prescribed

Eligibility Criteria

• Age: 4 Months - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Biliary atresia patients aged 0 to 3 years, who had a Kasai operation

You may not qualify if:

• The patients who had received liver transplantation

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (1)

• Lien TH, Bu LN, Wu JF, Chen HL, Chen AC, Lai MW, Shih HH, Lee IH, Hsu HY, Ni YH, Chang MH. Use of Lactobacillus casei rhamnosus to Prevent Cholangitis in Biliary Atresia After Kasai Operation. J Pediatr Gastroenterol Nutr. 2015 May;60(5):654-8. doi: 10.1097/MPG.0000000000000676.

  PMID: 25534776 DERIVED

MeSH Terms

Conditions

Biliary Atresia; Cholangitis

Interventions

Neomycin

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Digestive System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Mei-Hwei Chang, Professor

  National Taiwan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 14, 2005
• Study Start: December 1, 2003
• Primary Completion: January 1, 2012
• Study Completion: July 1, 2012
• Last Updated: August 21, 2013

Record last verified: 2013-08

Locations

TW (1)